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![]() ISO 9001/4:2000
![]() Summary of Differences ISO 9000 1994 - 2000
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| Author | Topic: Summary of Differences ISO 9000 1994 - 2000 |
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Andy Bassett Forum Contributor Posts: 274 |
I was at a presentation for the new ISO 9000.2000 today, and below is what the presenters said is the main difference with the new standard. 1. A new 'process oriented' structure is required. That was taken direct from the presentation (who gets sued for copyright Marc, me or you), and here is my take. If you have built a system that contains your company business processes, and if you are making an effort to continuosly review and refine the system, you are not going to have many problems. If you or your company has been doing ISO on the fly.....you are going to get problems ------------------ IP: Logged |
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Marc Smith Cheech Wizard Posts: 4119 |
There is another thread where some of this is addressed: https://elsmar.com/ubb/Forum15/HTML/000010.html Neither of us get sued because you summarized. Who (or what company) gave the presentation? [This message has been edited by Marc Smith (edited 22 March 2001).] IP: Logged |
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isodog unregistered |
Read the requirements for the Quality Manual. does not require coverage of "the requirements of this .... Standard. Listing the requirements is 90% of most QM's. BIG difference IP: Logged |
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Andy Bassett Forum Contributor Posts: 274 |
Marc - The company was TUV Rhineland in Germany. ISO Dog, sorry i did not understand your point. Do you want to have another go. Regards ------------------ IP: Logged |
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dptdog unregistered |
The ISO 9000:2000 does NOT require a "Quality manual covering the requirements of this Standard" (1994 language). It only requires a scope, procedures or reference thereto, and a description of the sequence and interaction of the processes (a flow chart?). If I interpret this correctly, and there is every opportunity I haven't, the Quality Opinions?? IP: Logged |
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isodog unregistered |
it is not importsant to know that dptdog and isodog are friends IP: Logged |
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Marc Smith Cheech Wizard Posts: 4119 |
quote:Can be. It really isn't any different than the 1994 version. The question then was did your quality manual have to be in some sort of format. The result was most companies used them but they were policy manuals with references. If you had an index with references and you could go to each reference and see that the standard was addressed you had no problem. This 'new' interpretation is not new. At best it's a clarification. You don't need the flow chart. Just the index. But - your references better restate the specific verbiage from the standard. You want no chance of your auditor saying "...you didn't specifically address XXXXX. Even if you don't do it (such as servicing and details within requirements) you still have to address it.... That'll be a Minor but you can fix it quickly with a few sentences". IP: Logged |
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isodog unregistered |
It is significantally different!!! The 1994 standard says 'the supplier shall prepare a quality manual covering the requirements of this standard. The quality manual shall inclusde or make referance to the quality-system procedures and outline the structure of the documetion used in the qualiry system. The 2000 revision sez "the quality manual shall be ......: Sounds like one page and a folw chart to me! IP: Logged |
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Marc Smith Cheech Wizard Posts: 4119 |
Nope - sorry... quote: Two main conditions. 1. ...or make reference to - need I say anything more than an index/matirx? 2. A document pyramid. No more, no less required there.
quote:Statement. quote:See above. quote:See the APQP file in the pdf files directory, I guess. I'm a flow chart freak so to me this is normal. Major systems are flow charted and they all flow down as sub-processes from the 'master' Input--->Output at the top. Numerous examples here on the site. [This message has been edited by Marc Smith (edited 22 March 2001).] IP: Logged |
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Marc Smith Cheech Wizard Posts: 4119 |
Oh! Throw in a Quality Policy! IP: Logged |
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isodog unregistered |
don't see amy reference to "outline the structure of the documentation..." in my DIS (25 Nov 1999) Level one is dead in ISO. And good riddance to a document consultants chargd up to $10,000 for and was usually never used after registration. Wonder what will happen in QS,AS and the other standards that claim they are value added? IP: Logged |
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Marc Smith Cheech Wizard Posts: 4119 |
Any company that paid US$10,000 for a quality manual was.... Well, stupid. I'll do it for 8K.... ![]() IP: Logged |
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isodug unregistered |
I'll bid $7,500. The happy news is YOU DON"T NEED THIS WORTHLESS DOG ANYMORE! We should be happy. Except those that like to charge $7,000 for a worthless document (except to impress a highly skilled and overtained auditor) Dave IP: Logged |
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Marc Smith Cheech Wizard Posts: 4119 |
From: ISO Standards Discussion Date: Mon, 1 May 2000 07:15:54 -0500 Subject: Re: Q: ISO 9000:2000 Elements? /Bradley/Paten From: Mike Paten [email protected] In a nut shell, the "20" elements of the 1994 standards have been replaced with "4" key business processes (or elements) to manage - each with a number of subprocesses or elements. To clarify: Sections 1, 2 and 3 of ISO 9001:1994 and Clauses 1,2 and 3 of ISO 9001:2000 are virtually the same - containing scope, references and definitions. Section 4 of ISO 9001:1994 defines quality systems requirements for each of the "twenty" quality system elements we've all grown accustomed to. Because the new standards are focused on quality system processes, Clause 4 of ISO 9001:2000 requires an organization to define these processes (or elements) and describe related documentation - this clause is essentially equivalent to section 4.2 of the old standard. Clauses 5 - 8 of the new standard defines specific requirements that must be addressed in four key "process" areas - which can be correlated to the standard process management (Plan, Do, Check, Act) cycle as follows: ? Plan Clause 5. Management responsibility - everything flows from management who define the requirements for the system Clause 6. Resource management - from these requirements the resources will be identified and management must ensure they are provided and applied within the system ? Do Clause 7. Product (and/or service) realization - the necessary process are established and carried out ? Check Clause 8. Measurement, analysis and improvement - the results will be measured, analyzed and opportunity for improvement identified ? Act Clause 8. Measurement, analysis and improvement - acting upon data identified in the check cycle, the suggestions for improvement can be implemented - directly or when fed into the Management Review process The requirement to continuously improve the quality system is one of the key changes imposed by the standard - hence the keywords differentiating the old and new standards: the "Transformation from Conformance to Performance". This is a highly generalized summary, but hopefully it answered your basic question. There's lots more to know and learn about the new standard. Thanks. Mike Paten IP: Logged |
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John C Forum Contributor Posts: 134 |
Some ISO 9001 requirements can only be decided by looking at the Standard as an integrated whole. The requirements for the quality manual come into this category; In section 1. Scope, we see that the purpose of ISO 9000 is to ensure that a quality system exists in order to provide and demonstrate the capability to supply conforming product, through compliance with the standard. Many people use (or should use) the documented system in any organisation. They use it for a variety of purposes but they are all concerned with this capability of supplying conforming product or the demonstration of this capability. The typical group is; registrar auditor, senior managers, customer reps, management rep, middle managers, supervisors, engineers, consultants, auditors, etc, but the system is also an integrated whole and all of these people need an overview of the system if they are to do their job effectively. In fact, widespread, general visibility and understanding of how the system works and how it complies with the standard, is crucial to its effective use and development and this can only be achieved by a fairly detailed system overview. This overview is, currently, the quality manual. If you remove the description of how compliance with the standard is achieved, you have to put it somewhere else and this makes no sense. If you just drop it, then youâll make a lot of peopleâs work more difficult and less effective and youâll certainly run into problems with the registrar auditor. You may claim, effectively, that the standard no longer requires it, but I think you will pay dearly for it when asked, therefore, to demonstrate compliance in an alternate way. My own preference is to produce a manual with this overview and several other important things in it, but not too long. It should be suitable to give to a visiting prospective customer, and be comfortably read after a shower and before dinner, along with an aperatif. The guy is there to find out if you can come up with the goods. If you hand him a single sheet with a bit of a flow chart on it, donât be surprised if you donât get the contract. Andy, As you say, If youâre correctly focused youâll be ok. If youâre ădoing ISO 9000 on the fly, youâre going to have problemsä. - Yes, of course they will. And, if they are, you can be sure they already have problems enough without bringing more down on themselves. The Standard exists to help meet business goals. The people who will find it difficult to change to the new version are those who never understood this and have built a system which sees compliance as an end in itself. The 2000 version attempts to broaden the scope so as to include things which good management would have covered anyway. Unfortunately, or fortunately for more competitive, well managed organisations, you canât legislate for good management and the ones who need the new version most will still find plenty of pitfalls to put their foot in. [This message has been edited by John C (edited 17 May 2000).] IP: Logged |
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Peter Hernandez Lurker (<10 Posts) Posts: 3 |
quote:In my company compliance is the only important thing. They want the certificate. They need it to make business. But they do no effort to understand what it all is about. ------------------ IP: Logged |
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Marc Smith Cheech Wizard Posts: 4119 |
quote:Which is the case 95% of the time... IP: Logged |
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